FDA Inspection
B & G Labs, IncB & G Labs, Inc – FDA Inspection, Nov 24, 2009
Record Details
This FDA Inspection record concerns B & G Labs, Inc, with an inspection on November 24, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- B & G Labs, Inc
- Inspection Date
- November 24, 2009
- Product Type
- Drugs
View Company Profile
ID · 4dc00f63-5af5-45c3-b29a-60d83ab673b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 629990
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.52Washing and toilet facilities are deficient
- 21 CFR 211.100(a)Approval and review of procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of B & G Labs, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2016 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| November 7, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 10, 2012 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for B & G Labs, Inc
- FDA Inspection 967721 - 2016-02-10
- FDA Inspection 903080 - 2014-11-07
- FDA Inspection 767080 - 2012-02-10
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